Efficacy and Safety Study of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe COPD

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A study multicenter, phase III, randomized, open label study to evaluate the efficacy and safety of a fixed-dose combination of formoterol/fluticasone and salmeterol/fluticasone in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) that will enroll 336 subjects aged ≥ 40 years, smokers or former smokers, diagnosed with chronic obstructive pulmonary disease, classified as moderate chronic obstructive pulmonary disease or severe according to GOLD spirometric classification. The subjects will be allocated in 2 parallel groups and will receive the medicines of study, according of the randomization during a 24-week.

Multicenter, Phase III, Randomized, Open Label Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Formoterol/Fluticasone and Salmeterol/Fluticasone in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).

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Smoker or ex-smoker of ≥ 10 pack-years [number of pack-years = number of daily cigarettes / 20 x number of years of smoking (eg t10 pack-years is equal to 20 cigarettes / day for 10 years, or 10 cigarettes per day within 20 years)].

Ability to fill out the patient's Diary

Ability to fill out the MRC dyspnea scale and questionnaires CAT and CDLM.

Subject who uses more than 2 alcohol drinks a day or> 14 drinks a week;

Subject with a history of malignancy or ≤ 5 years> 5 years, but without documentation of remission / cure.

Illiterate or individuals who have limitation in understanding the use of devices as well as an inability to understand the questionnaires and diary that will be applied; Exception: subject illiterate, but capable of understanding regarding the use of the device, the questionnaires and diaries of the study and make available for relatives who can fill the diary study.

History of hypersensitivity to study drugs and rescue;

Any other disease or therapy that in the opinion of the investigator would jeopardize the subject or interfere with the objective of the study;

Subject with a history of ineffectiveness of formoterol fumarate, to fluticasone or salmeterol xinafoate;

Subject who participated in another study within 1 (one) year;

Pregnant women or those with positive serum β-HCG;

Radiological change is not compatible with COPD;

Clinically significant ECG changes, as reported by the investigator;

Any other disease, therapy or laboratory abnormality which in the opinion of the investigator would jeopardize the subject or interfere with the objective of the study;

Use of medications prescribed in the exclusion criteria for visit V -2.

Subjects who had an exacerbation during the standardization that required systemic corticosteroids and / or antibiotics or hospitalization will not be eligible for randomization.